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  1. HOME
  2. Standards for How to import medical devices

How to import medical devices

How to import medical devices, Total:294 items.

The international standard classification for "How to import medical devices" includes: Medical equipment in general , Medical equipment .

The Chinese standard classification for "How to import medical devices" includes: Medical sanitary products , General and microsurgical devices , Medical apparatus and devices in general , Public medical equipment .

Professional Standard - Commodity Inspection

  • SN/T 0323.1-2007 Rules for the inspection of medical equipment for import and export - Part 1 : Infusion and transfusion sets for single use
  • SN/T 3061-2011 Rules of the Inspection of Packaging for Import Terminally Sterilized Medical Devices
  • SN/T 1430.1-2004 Rules for the inspection of medical electrical equipment for improt - Ultrasonic medical diagnostic and therapy equipment
  • SN/T 0323.2-2007 Rules for the inspection of medical equipment for import and export - Part 2 : Sterile hypodermic syringes for single use
  • SN/T 3062.2-2011 Packing Materials for Terminally Sterilized Medical Devices for Import. Part 2: Paper Bags. Requirements and Test Methods

国家质量监督检验检疫总局

  • SN/T 4445.2-2016 Technical requirements for the inspection of medical apparatus for import-Part 2: Patient monitor
  • SN/T 4445.1-2016 Technical requirements for the inspection of medical apparatus for import-Part 1: Medical electrical equipment

Professional Standard - Agriculture

  • SN/T 4445.3-2018 Technical requirements for the inspection of imported medical devices Part3 : Anaesthetic equipment
  • SN/T 4445.4-2023 Technical requirements for the inspection of medical equipment for importPart 4:Infusion pump

Professional Standard - Medicine

  • YY/T 0802.1-2024 Disposal of medical devices Information to be provided by the medical device manufacturer Part 1: Medium and high risk medical devices
  • YY/T 0468-2015 Medical devices―Quality management―Medical device nomenclature data structure
  • YY/T 0316-2008 Medical devices - Application of risk management to medical devices
  • YY/T 0316-2003 Medical devices -- Application of risk management to medical devices
  • YY/T 0802.2-2024 Disposal of medical devices - Information to be provided by the medical device manufacturer - Part 2: Low-risk medical devices
  • YY/T 0316-2016 Medical devices-Application of risk management to medical devices

General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China

  • GB/Z 42217-2022 Medical device —Validation of software for medical device quality system
  • GB/T 42062-2022 Medical devices—Application of risk management to medical devices

国家食品药品监督管理局

  • YY/T 1474-2016 Medical devices－Application of risk management to medical devices

Guangdong Provincial Standard of the People's Republic of China

  • DB4403/T 277-2022 Medical device unique identification data interface specification

国家药监局

  • YY/T 0802-2020 Processing of medical devices—Information to be provided by the medical device manufacturer

Group Standards of the People's Republic of China

GSO

  • GSO ISO 14971:2015 Medical devices -- Application of risk management to medical devices
  • BH GSO ISO 14971:2017 Medical devices -- Application of risk management to medical devices
  • OS GSO ISO 14971:2015 Medical devices -- Application of risk management to medical devices
  • BH GSO ISO 15225:2017 Medical devices -- Quality management -- Medical device nomenclature data structure
  • OS GSO IEC 62366:2014 Medical devices - Application of usability engineering to medical devices
  • GSO ISO 15225:2016 Medical devices -- Quality management -- Medical device nomenclature data structure
  • GSO ISO 17664-2:2023 Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices — Part 2: Non-critical medical devices
  • BH GSO ISO 17664-2:2023 Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices — Part 2: Non-critical medical devices

German Institute for Standardization

PL-PKN

Association Francaise de Normalisation

  • NF EN 1642:2013 Oral medicine - Medical devices for oral medicine - Dental implants
  • NF S99-211:2013 Medical devices - Application of risk management to medical devices
  • NF S90-191:1986 MEDICO-SURGICAL EQUIPMENT. GLASS BOTTLES FOR PERFUSION. GEOMETRICAL CHARACTERISTICS AND MARKING.
  • NF EN ISO 14971:2019 Medical devices - Application of risk management to medical devices
  • NF S99-211/A11*NF EN ISO 14971/A11:2021 Medical devices - Application of risk management to medical devices
  • NF EN ISO 14971/A11:2021 Medical devices - Application of risk management to medical devices
  • NF S98-116-2*NF ISO 17664-2:2021 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 2 : non-critical medical devices
  • NF S99-012:2010 Medical devices - Quality management - Medical device nomenclature data structure.
  • NF S99-401:1994 Dispositifs médicaux - Élastomère de silicone de qualité médicale
  • NF S98-136:2009 Sterilisation of medical devices - Risk management related to the preparation of sterile medical devices within health establishments.
  • NF EN 556-1:2002 Stérilisation des dispositifs médicaux - Exigences relatives aux dispositifs médicaux en vue d'obtenir l'étiquetage STERILE - Partie 1 : exigences relatives aux dispositifs médicaux stérilisés au stade terminal
  • NF S98-107-2*NF EN 556-2:2015 Sterilization of medical devices - Requirements for medical devices to be designated ''STERILE'' - Part 2 : requirements for aseptically processed medical devices

SCC

  • DIN 58254 E:2017 Draft Document - Medical instruments - Scissors for incisions
  • VDI 5707 BLATT 1-2023 Repeat tests on active medical devices in medical use — test principles
  • VDI 5707 BLATT 1-2023 Repeat tests on active medical devices in medical use — test principles
  • CAN/CSA-ISO 14971:2007(C2012) Medical devices - Application of risk management to medical devices
  • CEI UNI EN ISO 14971:2020 Medical devices - Application of risk management to medical devices
  • AAMI/ISO 14971:2019 Medical devices - Application of risk management to medical devices
  • DANSK DS/ISO 14971:2020 Medical devices – Application of risk management to medical devices
  • CAN/CSA-ISO 14971:2001(R2006) Medical Devices - Application of Risk Management to Medical Devices
  • DANSK DS/EN ISO 14971:2012 Medical devices – Application of risk management to medical devices
  • CAN/CSA-ISO 14971:2007(R2012) Medical Devices - Application of Risk Management to Medical Devices
  • ISO 14971:2019 Plus Redline Medical devices - Application of risk management to medical devices
  • CAN/CSA-ISO 14971:2001(C2006) Medical devices - Application of risk management to medical devices
  • BS EN ISO 14971:2019 Medical devices. Application of risk management to medical devices
  • DANSK DS/EN 62366:2008 Medical devices - Application of usability engineering to medical devices
  • AENOR UNE-EN 62366:2009 Medical devices - Application of usability engineering to medical devices
  • CEI EN 62366:2008 Medical devices - Application of usability engineering to medical devices
  • AAMI/IEC 62366:2007 Medical devices - Application of usability engineering to medical devices
  • AAMI/ISO 15225:2010 Medical devices - Quality management - Medical device nomenclature data structure
  • AAMI/ISO 15225:2016 Medical devices - Quality management - Medical device nomenclature data structure
  • DANSK DS/EN ISO 15225:2016 Medical devices – Quality management – Medical device nomenclature data structure
  • CEI UNI EN/ISO 15225:2016 Medical devices - Quality management - Medical device nomenclature data structure
  • AENOR UNE-EN 62366/A1:2009 Medical devices - Application of usability engineering to medical devices
  • CEI EN 62366/A1:2008 Medical devices - Application of usability engineering to medical devices
  • MIL MIL-C-42068-1989 CHEST, MEDICAL INSTRUMENT AND SUPPLY SET
  • DANSK DS/EN 62366/A1:2008 Medical devices - Application of usability engineering to medical devices
  • AAMI/ISO 17664-2:2022 Processing of health care products—Information to be provided by the medical device manufacturer for the processing of medical devices—Part 2: Non-critical medical devices
  • CSA ISO 17664-2:2023 Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices — Part 2: Non-critical medical devices
  • DANSK DS/ISO 17664-2:2021 Processing of health care products – Information to be provided by the medical device manufacturer for the processing of medical devices – Part 2: Non-critical medical devices
  • DIN 96056:2016 Medical instruments - Bone raspatory
  • DIN 58857:2019 Medical instruments - Directors
  • NS-EN 13824:2004 Sterilization of medical devices — Aseptic processing of liquid medical devices — Requirements
  • BS PD ISO/TR 80002-2:2017 Medical device software-Validation of software for medical device quality systems
  • CAN/CSA-ISO 17664-2-2023 Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices — Part 2: Non-critical medical devices
  • SN-CR 14060:2000 Medical device traceability
  • AAMI/ISO 17664-1:2022 Processing of health care products—Information to be provided by the medical device manufacturer for the processing of medical devices—Part 1: Critical and semi-critical medical devices
  • DANSK DS/ISO 17664-1:2021 Processing of health care products – Information to be provided by the medical device manufacturer for the processing of medical devices – Part 1: Critical and semi-critical medical devices
  • NS-EN ISO 14971:2007 Medical devices - Application of risk management to medical devices (ISO 14971:2007)
  • NS-EN 556:1994 Sterilization of medical devices — Requirements for medical devices to be labelled "Sterile"
  • NS-EN ISO 14971:2019 Medical devices — Application of risk management to medical devices (ISO 14971:2019)
  • AENOR UNE-EN ISO 14971:2020 Medical devices - Application of risk management to medical devices (ISO 14971:2019)
  • DANSK DS/EN 556-1/AC:2006 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices
  • CSA Z314.4-M1979-1979 Industrial Sterilization of Medical Devices by the Steam Process
  • NS-EN 556-1:2001 Sterilization of medical devices — Requirements for medical devices to be designated "STERILE" — Part 1: Requirements for terminally sterilized medical devices
  • CAN/CSA Z314.5-1988 Industrial Sterilization of Medical Devices by the Ethylene Oxide Process
  • NS-EN ISO 17664-2:2023 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 2: Non-critical medical devices (ISO 17664-2:2021)
  • CAN/CSA Z314.4-1987 Industrial Sterilization of Medical Devices by the Steam Process
  • CSA Z314.5-1979 Industrial Sterilization of Medical Devices by the Ethylene Oxide Process
  • NS-EN 556-2:2003 Sterilization of medical devices — Requirements for medical devices to be designated "STERILE" — Part 2: Requirements for aseptically processed medical devices
  • AENOR UNE-EN 556-2:2016 Sterilization of medical devices - Requirements for medical devices to be designated ''STERILE" - Part 2: Requirements for aseptically processed medical devices
  • NS-EN 556-2:2015 Sterilization of medical devices — Requirements for medical devices to be designated "STERILE" — Part 2: Requirements for aseptically processed medical devices
  • CAN/CSA-Z314.4-1987 Industrial Sterilization of Medical Devices by the Steam Process
  • CAN/CSA-Z314.5-1988 Industrial Sterilization of Medical Devices by the Ethylene Oxide Process
  • DANSK DS/EN ISO 17664-2:2024 Processing of health care products – Information to be provided by the medical device manufacturer for the processing of medical devices – Part 2: Non-critical medical devices (ISO 17664-2:2021)
  • DANSK DS/EN 556-2:2015 Sterilization of medical devices - Requirements for medical devices to be designated ''STERILE" - Part 2: Requirements for aseptically processed medical devices
  • DANSK DS/EN 556-1:2001 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices
  • DIN EN 556-2 E:2014 Draft Document - Sterilization of medical devices - Requirements for medical devices to be designated ''STERILE'' - Part 2: Requirements for aseptically processed medical devices; German version prEN 556-2:2014
  • NS-EN 556-1:2024 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices
  • CAN/CSA-ISO 17664-1-2023 Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices — Part 1: Critical and semi-critical medical devices
  • BS PD IEC/TR 80002-1:2009 Medical device software-Guidance on the application of ISO 14971 to medical device software
  • DIN 58318:2019 Medical instruments - Elevators Langenbeck's
  • DIN 96057:2016 Medical instruments - Raspatory type Sedillot
  • DIN 13184:2016 Medical instruments - Bone holding forceps Farabeuf's
  • NS-EN ISO 15225:2016 Medical devices — Quality management — Medical device nomenclature data structure (ISO 15225:2016)
  • DIN 58274:2016 Medical instruments - Iris forceps
  • NS-EN ISO 15225:2010 Medical devices — Quality management — Medical device nomenclature data structure (ISO 15225:2010)
  • DIN EN 556-1 E:2023 Draft Document - Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices; German and English version prEN 556-1:2023
  • DIN 58319:2019 Medical instruments - Elevators Williger
  • AAMI/ISO 17664:2017 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices.
  • CAN/CSA-ISO 14971-2021 Medical devices – Application of risk management to medical devices (ISO 14971:2019, IDT)
  • ISO 14971:2000/AMD1:2003 Amendment 1 - Medical devices - Application of risk management to medical devices
  • DANSK DS/EN ISO 17664-1:2021 Processing of health care products – Information to be provided by the medical device manufacturer for the processing of medical devices – Part 1: Critical and semi-critical medical devices (ISO 17664-1:2021)
  • NS-EN ISO 17664-1:2021 Processing of health care products – Information to be provided by the medical device manufacturer for the processing of medical devices – Part 1: Critical and semi-critical medical devices (ISO 17664-1:2021)

EU/EC - European Union/Commission Legislative Documents

  • MEDDEV 2.15-2008 GUIDELINES ON MEDICAL DEVICES Committees/Working Groups contributing to the implementation of the Medical Device Directives (REV 3)

US-CFR-file

  • CFR 21-803.3-2013 Food and Drugs. Part803:Medical device reporting; (Eff. Until 8-14-15). Section803.3:How does FDA define the terms used in this part?
  • CFR 21-803.3-2014 Food and Drugs. Part803:Medical device reporting (Eff. 8-14-15). Section803.3:How does FDA define the terms used in this part?
  • CFR 21-803.40-2014 Food and Drugs. Part803:Medical device reporting (Eff. 8-14-15). Section803.40:If I am an importer, what reporting requirements apply to me?
  • CFR 21-803.20-2014 Food and Drugs. Part803:Medical device reporting (Eff. 8-14-15). Section803.20:How do I complete and submit an individual adverse event report?
  • CFR 21-803.12-2014 Food and Drugs. Part803:Medical device reporting (Eff. 8-14-15). Section803.12:How do I submit initial and supplemental or followup reports?

RU-GOST R

  • GOST ISO 14971-2011 Medical devices. Application of risk management to medical devices
  • GOST R IEC 62366-2013 Medical devices. Application of usability engineering to medical devices
  • GOST R ISO 15225-2014 Medical devices. Quality management. Medical device nomenclature data structure
  • GOST ISO 10993-13-2016 Medical devices. Biological evaluation of medical devices. Part 13. Identification and quantification of degradation products from polymeric medical devices
  • GOST EN 556-1-2011 Sterilization of medical devices. Requirements for medical devices to be designated «sterile». Part 1. Requirements for terminally sterilized medical devices
  • GOST ISO 10993-13-2011 Medical devices. Biological evaluation of medical devices. Part 13. Identification and quantification of degradation products from polymeric medical devices

Japanese Industrial Standards Committee (JISC)

  • JIS T 14971:2003 Medical devices -- Application of risk management to medical devices
  • JIS T 14971:2012 Medical devices -- Application of risk management to medical devices

Korean Agency for Technology and Standards (KATS)

  • KS P ISO 14971:2021 Medical devices — Application of risk management to medical devices
  • KS P ISO 14971:2018 Medical devices — Application of risk management to medical devices
  • KS P ISO 15225-2023 Medical devices — Quality management — Medical device nomenclature data structure
  • KS P ISO 15225-2014(2019) Medical devices — Quality management — Medical device nomenclature data structure
  • KS P ISO 17664-1:2021 Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices — Part 1: Critical and semi-critical medical devices

European Committee for Standardization (CEN)

  • EN ISO 14971:2012 Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
  • CENELEC EN 62366-2008 Medical devices - Application of usability engineering to medical devices
  • EN 556:1994 Sterilization of Medical Devices - Requirements for Medical Devices to Be Labelled `Sterile'
  • EN ISO 17664-1:2021 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 1: Critical and semi-critical medical devices (ISO 17664-1:2021)
  • EN ISO 14971:2019/A11:2021 Medical devices - Application of risk management to medical devices (ISO 14971:2019)

KR-KS

  • KS P ISO 14971-2018 Medical devices — Application of risk management to medical devices
  • KS P ISO 14971-2021 Medical devices — Application of risk management to medical devices
  • KS P ISO 17664-2-2022 Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices — Part 2: Non-critical medical devices
  • KS P ISO 17664-1-2021 Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices — Part 1: Critical and semi-critical medical devices

British Standards Institution (BSI)

  • BS EN ISO 14971:2009 Medical devices - Application of risk management to medical devices
  • BS EN 62366-1:2015+A1:2020 Medical devices. Application of usability engineering to medical devices
  • BS EN 62366-1:2015 Medical devices. Application of usability engineering to medical devices
  • BS EN ISO 14971:2012 Medical devices. Application of risk management to medical devices
  • BS PD IEC/TR 62366-2:2016 Medical devices. Guidance on the application of usability engineering to medical devices
  • BS EN ISO 14971:2001 Medical devices - Application of risk management to medical devices
  • BS EN ISO 14971:2019+A11:2021 Medical devices - Application of risk management to medical devices
  • BS EN ISO 15225:2010 Medical devices - Quality management - Medical device nomenclature data structure
  • BS EN 556-1:2024 Sterilization of medical devices. Requirements for medical devices to be designated "STERILE" - Requirements for terminally sterilized medical devices
  • BS EN 556-2:2015 Sterilization of medical devices. Requirements for medical devices to be designated 'STERILE'. Requirements for aseptically processed medical devices
  • BS EN ISO 15225:2016 Medical devices. Quality management. Medical device nomenclature data structure
  • BS ISO 17664-2:2021 Processing of health care products. Information to be provided by the medical device manufacturer for the processing of medical devices. Non-critical medical devices
  • BS EN 556-1:2001(2006) Sterilization of medical devices — Requirements for medical devices to be designated "STERILE" — Part 1 : Requirements for terminally sterilized medical devices

CEN - European Committee for Standardization

  • EN ISO 14971:2007 Medical devices - Application of risk management to medical devices
  • EN ISO 14971:2000 Medical Devices - Application of Risk Management to Medical Devices (Incorporates Amendment A1: 2003)
  • EN ISO 14971:2009 Medical devices - Application of risk management to medical devices
  • EN ISO 14971:2019 Medical devices - Application of risk management to medical devices
  • EN 13824:2004 Sterilization of medical devices - Aseptic processing of liquid medical devices - Requirements

International Organization for Standardization (ISO)

  • ISO 14971:2019 Medical devices — Application of risk management to medical devices
  • ISO 14971:2000 Medical devices - Application of risk management to medical devices
  • IEC 62366:2007 Medical devices - Application of usability engineering to medical devices
  • ISO 17664-1:2021 Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices — Part 1: Critical and semi-critical medical devices
  • IEC/TR 62366-2:2016 Medical devices — Part 2: Guidance on the application of usability engineering to medical devices
  • IEC TR 62366-2-2016 Medical devices — Part 2: Guidance on the application of usability engineering to medical devices

South African Bureau of Standard

  • SANS 14971:2008 Medical devices - Application of risk management to medical devices

TH-TISI

  • TIS 14971-2013 Medical devices.application of risk management to medical devices

International Electrotechnical Commission (IEC)

  • IEC 62366:2014 Medical devices - Application of usability engineering to medical devices
  • IEC 62366-1:2015 Medical devices - Part 1: Application of usability engineering to medical devices
  • IEC TR 62366-2:2016 Medical devices - Part 2: Guidance on the application of usability engineering to medical devices
  • IEC 62366:2007/AMD1:2014 Medical devices - Application of usability engineering to medical devices

Spanish Association for Standardization (UNE)

  • UNE-EN ISO 14971:2020/A11:2022 Medical devices - Application of risk management to medical devices (ISO 14971:2019)
  • UNE-EN ISO 14971:2020 Medical devices - Application of risk management to medical devices (ISO 14971:2019)
  • UNE-EN 13824:2005 Sterilization of medical devices - Aseptic processing of liquid medical devices - Requirements
  • UNE-EN 556-1:2002 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices
  • UNE-EN 556-2:2016 Sterilization of medical devices - Requirements for medical devices to be designated ''STERILE" - Part 2: Requirements for aseptically processed medical devices
  • UNE-EN 556-1:2002/AC:2007 Sterilization of medical devices - Requirements for medical devices to be designated 'STERILE' - Part 1: Requirements for terminally sterilized medical devices
  • UNE-EN ISO 14971:2001 Medical devices - Application of risk management to medical devices. (ISO 14971:2000)
  • UNE-EN ISO 14971:2007 Medical devices - Application of risk management to medical devices (ISO 14971:2007)
  • UNE-EN ISO 17664-1:2022 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 1: Critical and semi-critical medical devices (ISO 17664-1:2021)
  • UNE-EN 556-2:2004 Sterilization of medical devices - Requirements for medical devices to be designated STERILE - Part 2: Requirements for aseptically processed medical devices

American National Standards Institute （ANSI)

  • ANSI/AAMI/ISO 14971:2019 Medical devices— Application of risk management to medical devices
  • ANSI/AAMI/ISO 17664-2:2022 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 2: Non-critical medical devices
  • ANSI/AAMI/ISO 15225:2016 Medical devices—Quality management—Medical device nomenclature data structure
  • ANSI/AAMI/ISO 17664-1:2022 Processing of health care products -Information to be provided by the medical device manufacturer for the processing of medical devices - Part 1: Critical and semi-critical medical devices
  • ANSI/AAMI/IEC 62366/A1:2014 Medical devices - Application of usability engineering to medical devices - Amendment 1

Standard Association of Australia （SAA）

  • AS ISO 14971:2020 Medical devices — Application of risk management to medical devices

Danish Standards Foundation

  • DS/EN ISO 14971:2013 Medical devices - Application of risk management to medical devices
  • DS/EN ISO 15225:2010 Medical devices - Quality management - Medical device nomenclature data structure
  • DS/EN 62366:2008 Medical devices - Application of usability engineering to medical devices
  • DS/CEN/CR 14060:2001 Medical device traceability
  • DS/EN 556-1/AC:2006 Sterilization of medical devices - Requirements for medical devices to be designated ""STERILE"" - Part 1: Requirements for terminally sterilized medical devices
  • DS/EN 556-2:2004 Sterilization of medical devices - Requirements for medical devices to be designated ""STERILE"" - Part 2: Requirements for aseptically processed medical devices
  • DS/EN 556-1:2002 Sterilization of medical devices - Requirements for medical devices to be designated ""STERILE"" - Part 1: Requirements for terminally sterilized medical devices

CENELEC - European Committee for Electrotechnical Standardization

  • EN 62366:2008 Medical devices - Application of usability engineering to medical devices

DIN

  • DIN EN 13824:2005 Sterilization of medical devices - Aseptic processing of liquid medical devices - Requirements
  • DIN 96056:2023 Medical instruments - Bone raspatory
  • DIN 13173:2023 Medical instruments - Dressing forceps
  • DIN EN ISO 17664-2:2024 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 2: Non-critical medical devices (ISO 17664-2:2021); German version EN ISO 17664-2:2023

Canadian Standards Association (CSA)

  • CAN/CSA-ISO 14971:2007 Medical Devices - Application of Risk Management to Medical Devices (Second Edition)
  • CSA ISO 14971-07-CAN/CSA:2007 Medical Devices - Application of Risk Management to Medical Devices second edition
  • CAN/CSA-ISO 17664:2018 Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices

Lithuanian Standards Office

  • LST EN 556-1-2002 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices
  • LST EN 556-2-2004 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2: Requirements for aseptically processed medical devices
  • LST EN ISO 15225:2010 Medical devices - Quality management - Medical device nomenclature data structure (ISO 15225:2010)
  • LST EN 556-1-2002/AC-2006 Sterilization of medical devices - Requirements for medical devices to be designated 'STERILE' - Part 1: Requirements for terminally sterilized medical devices

US-FCR

AT-ON

  • OENORM EN ISO 17664-1:2021 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 1: Critical and semi-critical medical devices (ISO/FDIS 17664-1:2021)

CH-SNV

  • SN EN ISO 17664-1:2021 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 1: Critical and semi-critical medical devices (ISO 17664-1:2021)

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